FDA’s ‘Exploratory’ MUsT Won't Affect OTC Sunscreen Rulemaking Schedule

29 Mar 2018

FDA’s plans for a maximal usage study to better understand sunscreen ingredient absorption should not hold up delivery of a final OTC sunscreen monograph by the end of 2019, the agency says. There are questions among industry stakeholders as to how FDA’s research relates to MUsTs currently requested from TEA sponsors seeking GRASE approvals.

FDA remains on track to finalize the OTC sunscreen drug monograph by the end of 2019, and its planned study to gain insight into sunscreen ingredient absorption should not derail those efforts, according to the agency.

A spokesperson for the Center for Drug Evaluation and Research confirmed March 28 that FDA “is interested in understanding whether,...